In order to clarify the scope of extended dosing, recommend the methods of extended dosing, elaborate on the key points of ethical review, discuss the supporting policies of the study sites, and protect the rights and interests of the subjects receiving extended dosing, China Anti-Cancer Association Chinese Oncology Clinical Trials Auditing Group has associated with the clinical trial institutions of well-known cancer hospitals in China to carry out studies and draft this consensus. The consensus could provide advice and guidance for clinical trials of registered anti-tumor drugs.